EP0888744A2 - In vivo Nullabgleich eines Druckmessfühlers - Google Patents

In vivo Nullabgleich eines Druckmessfühlers Download PDF

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Publication number
EP0888744A2
EP0888744A2 EP98305250A EP98305250A EP0888744A2 EP 0888744 A2 EP0888744 A2 EP 0888744A2 EP 98305250 A EP98305250 A EP 98305250A EP 98305250 A EP98305250 A EP 98305250A EP 0888744 A2 EP0888744 A2 EP 0888744A2
Authority
EP
European Patent Office
Prior art keywords
pressure sensor
pressure
aperture
sensor element
disposed
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP98305250A
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English (en)
French (fr)
Other versions
EP0888744B1 (de
EP0888744A3 (de
Inventor
Alan Coombes
Eric J. Brown
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DePuy Products Inc
Original Assignee
Johnson and Johnson Professional Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Johnson and Johnson Professional Inc filed Critical Johnson and Johnson Professional Inc
Publication of EP0888744A2 publication Critical patent/EP0888744A2/de
Publication of EP0888744A3 publication Critical patent/EP0888744A3/de
Application granted granted Critical
Publication of EP0888744B1 publication Critical patent/EP0888744B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02156—Calibration means

Definitions

  • Some catheter pressure sensors permit calibration to be performed in vivo.
  • One such catheter is described in U.S. Patent No. 4,901,735 (von Berg) in which a balloon structure surrounds the entire catheter tip, where the sensor is located, and is inflated when calibration is performed. With the balloon inflated, a uniform pressure is exerted on both surfaces of a strain gauge sensor.
  • Another catheter pressure sensor permitting in vivo zeroing is described in U.S. Patent No. 5,203,340 (Gustafson et al.) in which an ex vivo pressure connecting means is provided for inhibiting liquid communication with the reference surface of the sensor and permitting the physiological pressure to be applied to both surfaces of the sensor.
  • the invention comprises a catheter-based physiological pressure sensing device that can be formed within a catheter.
  • the pressure sensing device is preferably in the form of a bulb-like device that is formed within a catheter, such as at a distal end of the catheter.
  • the pressure sensing device includes a pressure sensor tip having an external wall and an aperture disposed in the external wall for providing a passageway between the outside and inside of the catheter.
  • a pressure sensor element is disposed within the pressure sensor tip with a first surface that is exposed to the aperture and an opposed second surface that is isolated from the aperture. The pressure sensor element separates the bulb-like device into separate and isolatable chambers.
  • a blocking element such as a balloon, is disposed in a first chamber that is defined by the first surface of the pressure sensor element and a wall of the device that includes the aperture.
  • the blocking element is adapted for selectively blocking the aperture. In a first position or condition, the blocking element occludes the aperture to effectively seal the first chamber with respect to the exterior of the catheter. When the blocking element is in a second condition, the first surface of the pressure sensor element is exposed to an external or physiological pressure via the aperture.
  • a catheter 10 is shown to have a proximal end 14 and a distal end 16.
  • the distal end 16 includes a tip region 20 and is adapted for being inserted into a patient for performing an in vivo physiological pressure measurement, such as the monitoring of intracranial pressure.
  • each of the branch tubes 28, 30 is coupled to the catheter tube 24 via respective Y-connectors 32, 34 and permit infusion or extraction of a liquid or gas from the tip region 20.
  • each of the branch tubes 28, 30 includes a respective coupling 36, 38, such as a syringe or fluid coupling.
  • the tip region 20 includes a first chamber 44 adapted for being exposed to the physiological pressure to be measured and a second chamber 48 adapted for being exposed to a reference pressure. During in vivo calibration, however, both chambers 44 and 48 are exposed to a reference pressure, as will be described.
  • the pressure sensor element 40 separates and isolates the first and second chambers 44,48.
  • the pressure sensor element 40 is mounted in the tip region 20 so that the first chamber 44 is disposed adjacent to one surface 40a of the sensor element 40 and the second chamber 48 is disposed adjacent to an opposite surface 40b of the sensor element 40, as shown.
  • the pressure sensor element 40 extends along its length between a terminal portion 50 of the tip region 20 and a barrier portion 52. Ends 41a,b of the pressure sensor element 40 are bonded to the terminal and barrier portions 50,52 with an adhesive.
  • the adhesive provides a respective seal between along the ends 41a,b of the pressure sensor element 40 and the respective terminal and barrier portions 50,52.
  • the pressure sensor 40 also extends across the diameter of tube 66.
  • the pressure sensor element 40 is mounted within the tube 66 and edges of the pressure sensor element 40 are bonded to walls of the tube.
  • the adhesive extends along the edges of the pressure sensor element 40 to form a seal between the tube 66 and the pressure sensor element edges.
  • the pressure sensor element 40 is bonded about its perimeter with an adhesive that provides a seal to effectively isolate the first and second chambers 44,48.
  • the first and second chambers 44 and 48 are isolated from one another but need not be of equal size.
  • the pressure sensor 40 can be positioned within the tube 66 so as to form two chambers of unequal size.
  • the adhesive used to bond the pressure sensor element 40 can be selected from suitable non-conductive, biocompatible, medical grade adhesives, such as epoxies and silicone adhesives.
  • the barrier portion 52 is comprised of silicone or medical grade adhesive described above, such as an epoxy, that secures the tube 66 to the tube 24.
  • the terminal portion 50 is formed from silicone, for example, secured to an end of the catheter tube 66.
  • the catheter tube 24 abuts the tube 66.
  • the catheter tube 24 may have an outer diameter smaller than an inner diameter of the tube 66 such that the catheter tube 24 can be inserted within the tube 66.
  • the tubes 24,66 can be bonded with an adhesive or by other means. Further, the diameter and wall thickness of the tubes 24, 66 can vary significantly without departing from the intended scope of the invention.
  • the tip region 20 includes an aperture 60 extending through a wall of the tube 66 to selectively expose the first chamber 44 to a physiological pressure external to the catheter 10. More particularly, in accordance with the invention, a blocking element 64 is provided for selectively blocking the aperture 60, as will be described. Physiological pressure measurements are made when the aperture 60 is unblocked and the pressure sensor 40 is calibrated, or zeroed, when the aperture 60 is blocked.
  • the tube 66 is comprised of titanium.
  • MRI Magnetic Resonance Imaging
  • a cylindrical member 68 extends between the balloon 64 and the proximal end 14 or respective coupling 36, 38 of the catheter via the passageway beginning at the tube 24 ( Figure 1).
  • the cylindrical member 68 carries a gas or a fluid to and from the balloon 64 for inflating and deflating the balloon.
  • Cylindrical member 68 can be connected to a syringe, or other air supply, via a luer connector for example, to inflate the balloon. The syringe may be removed to deflate the balloon.
  • a first cylindrical member 70 extends from the first chamber 44 through the tube 24 to the proximal end 14.
  • the cylindrical member 70 is hollow and is adapted for carrying a gas to the first chamber 44 in order to calibrate the pressure sensor 40. More specifically, the gas directed into the first chamber 44 by the cylindrical member 70 is at the same pressure as a gas presented to the second chamber 48 during calibration.
  • a second cylindrical member 74 extends between the second chamber 48 and the proximal end 14 of the catheter through the tube 24. The second cylindrical member 74 is adapted to carry gas at a reference pressure to the second chamber during calibration and during physiological pressure measurements.
  • the second cylindrical member 74 is kept open to consistently expose one surface 40b of the pressure sensor element to atmospheric pressure.
  • air at atmospheric pressure is present in the second chamber 48 during calibration and during pressure measurements.
  • the first cylindrical member 70 is closed while physiological pressure measurements are made. This allows external pressure to be presented to the other surface 40a of the pressure sensor element.
  • the first cylindrical member 70 is opened to expose the other surface 40a of the pressure sensor element to atmospheric pressure.
  • both surfaces 40a,b of the pressure sensor element are exposed to atmospheric pressure.
  • the pressurized fluid source 35 ( Figure 1) provides gas to the first and second chambers 44,48 at a predetermined pressure during calibration.
  • the pressurized fluid source 35 is selectively coupled to both the first and second cylindrical members 70,74.
  • the pressurized gas ensures that the same pressure is present at both surfaces 40a,b of the pressure sensor element to more accurately zero the pressure sensor.
  • the pressurized gas such as air, overcomes any pressure differentials that can be caused by residual fluid in a chamber 44,48, from a physiological pressure measurement for example. Also, for atmospheric pressure, small differences in pressure can exist between the first and second chambers 44,48 due to the relatively long path from the connector 31 to the tip region 20.
  • the pressurized gas provides a substantially equalized pressure distribution in the first and second chambers 44,48 for accurate calibration.
  • a cylindrical member 80 is mounted in the silicon barrier region 52 between the balloon 64 and the first surface 40a of the pressure sensor 40. As is apparent from Figure 2, the cylindrical member 80 surrounds a portion of the pressure sensor element 40. A portion 85 of the cylindrical member 80 provides a backing plate when the balloon 64 is inflated to prevent the balloon from contacting and/or otherwise affecting the accuracy of measurements made by the pressure sensor 40. That is, the backing plate prevents any strain from being exerted by the blocking element 64 on the first side 40a of the pressure sensor 40.
  • the cylindrical member 80 provides a backing plate for the blocking element 64, the cylindrical member 80 cannot mechanically interfere with the mounting of the pressure sensor element 40 in the tube 66. More specifically, edges of the pressure sensor element 40 must extend across the diameter of the tube. To this end, the cylindrical member 80 includes at least one gap, groove, or other such opening that allows the pressure sensor element 40 to extend to the walls of the tube 66. It is understood that the cylindrical member 80 can have many configurations that provide the backing plate function for the blocking element 64 without preventing the pressure sensor element 40 from extending to the walls of the tube 66. For example, the cylindrical member 80 may only be present in the first chamber 44 where the blocking element 64 is located.
  • the cylindrical member 80 can provide further structural rigidity to the tip region 20 of the catheter.
  • a portion 84 of the cylindrical member can be affixed to the tube 66 by bonding with an adhesive, by ultrasonic welding or by other means.
  • An electrical conductor 78 is coupled between the pressure sensor element 40 and the connector 31 ( Figure 1) for electrical connection to the pressure monitoring circuit 33.
  • the electrical conductor 78 carries an electrical output signal of the pressure sensor 40 indicative of a measurement of the difference in pressures presented to the first and second sides 40a, 40b of the pressure sensor 40.
  • the pressure sensor 40 and pressure monitoring circuit 33 thus provide electronics for measuring a physiological pressure.
  • Cylindrical members 68, 70 and 74 as well as electrical conductor 78 extend through the barrier region 52 into the tube 24. With this arrangement, the tip region 20, and in particular the first chamber 44 and the second chamber 48, remain isolated from the environment within the tube 24.
  • the catheter tip region 20 has a diameter in the range of about one quarter to five millimeters, and preferably about two millimeters.
  • the length of the tip region 20 can range from about one to ten millimeters, is typically between three and five millimeters, and most preferably is about four millimeters.
  • the electrical output signal of the pressure sensor 40 carried by conductor 78 is indicative of the pressure differential between the first chamber 44 and the second chamber 48.
  • an output signal carried by the electrical conductor 78 is null.
  • the output signal carried by conductor 78 is processed by the pressure monitor circuit 33.
  • the pressure monitor circuit 33 includes a Wheatstone bridge measurement circuit.
  • the bridge circuit matches two resistances that correspond to the surfaces 40a,b of the pressure sensor element 40 with two resistors in the pressure monitoring circuit.
  • the bridge circuit provides an output that is proportional to the amount of mismatch between resistors caused by the output signal.
  • the resistance mismatch can be the result of pressure applied to the pressure sensor element or a drift in resistance not attributable to pressure.
  • the pressure monitoring circuit can compensate for the drift in resistance with an interface element or with a device in the pressure monitoring circuit that stores and subtracts drift measurements.
  • the pressure monitoring unit can include a display, such as a liquid crystal display (LCD), alarms, and peak positive and negative signal detection circuits.
  • LCD liquid crystal display
  • Step 90 Calibration of the pressure sensor 40 can be initiated, in step 90, either manually by a user at desired time intervals or, alternatively, automatically, such as at predetermined time intervals, under the control of the pressure monitoring circuit 33.
  • the balloon 64 is inflated in step 92 to the position shown in Figure 2 such that it blocks aperture 60.
  • the first chamber 44 is isolated from the physiological pressure exterior to the catheter 10.
  • a reference pressure such as atmospheric pressure, is introduced through cylindrical member 70 into the first chamber 44 and through cylindrical member 74 into the second chamber 48.
  • the output signal 78 of the pressure sensor 40 is then measured by the pressure monitoring circuit 33 to determine the zero offset of the pressure sensor in step 96.
  • the measured zero offset is used by the pressure monitoring circuit 33 to compensate for the zero offset and to thereby enhance the accuracy of subsequent pressure measurements.
  • a Wheatstone bridge circuit is used to detect resistance changes. The two resistance values from the respective surfaces of the pressure sensor element are matched with two resistors in the pressure monitoring circuit 33 to form the bridge circuit. As resistances change due to pressure applied to one or more surfaces of the pressure sensor element or resistances drift, the bridge circuit provides an output signal proportional to the resistance mismatch in the bridge. In this way, the pressure at the sensor element can be measured. For resistance drift, a circuit element in the pressure monitoring circuit can compensate for the resistance mismatch in the bridge circuit to zero the pressure sensor.
  • the pressure circuit includes a circuit to store and subtract resistance drift.
  • a tip region 100 comprising a pressure sensor permitting in vivo zeroing in accordance with the invention.
  • the tip region 100 is suitable for use with the catheter 10 of Figure 1.
  • the tip region 100 includes a terminal region 104 and a barrier region 108 between which a pressure sensor element 110, such as a semiconductor element, is mounted.
  • the pressure sensor 110 effectively divides the tip region 100 into two isolated chambers: a first chamber 112 adjacent to a first side 110a of the sensor and a second chamber 114 adjacent to a second side 110b of the sensor.
  • the first chamber 112 is bounded by a portion of the tip region wall or tube 122, the terminal region 104, the first sensor surface 110a and the barrier region 108 and the second chamber 114 is bounded by a portion of the tube 122, the terminal portion 104, the second sensor surface 110b and the barrier region 108, as shown.
  • the pressure sensor 110 is adhesively bonded to the tube 122 and the terminal and barrier portions 104, 108. The adhesive provides a seal to isolate the first and second chambers 112, 114.
  • a physiological pressure is measured while the balloon 124 is in the deflated condition, as shown in Figure 4A, to expose the first side 110a of the pressure sensor element 110 to the physiological pressure at the site at which the catheter is disposed.
  • a reference pressure is presented to the second side 110b of the pressure sensor element via tube 132 so that a differential pressure between the first and second sides of the pressure sensor element 110 can be measured.
  • the pressure sensor element 110 provides an output signal indicative of the pressure differential between the first and second chambers 112,114.
  • the output signal is carried by conductor 130 to a pressure monitoring circuit, like that shown and described in conjunction with Figure 2.
  • An optional cylindrical member 126 is embedded in the barrier region 108 to provide a backing plate for the balloon 124 and increase structural stability for the tip region 100 and barrier region 108 junction.
  • the cylindrical member 126 does not extend into the first and second chambers 112, 114, but, rather, terminates at a wall 128 of the barrier region 108.
  • the tip region 100 is increased in length due to the placement of the aperture 120 with respect to the pressure sensor element 110, but has a similar diameter.
  • the cylindrical member 126 can be a tube and will not interfere with the mounting of the pressure sensor element 110 in the tube 122, as in Figure 2. If the cylindrical member is not present, a portion of the barrier region 108 proximate the aperture provides the backing plate function for the balloon.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measuring Fluid Pressure (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
EP98305250A 1997-07-02 1998-07-01 In vivo Nullabgleich eines Druckmessfühlers Expired - Lifetime EP0888744B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/887,481 US6120457A (en) 1997-07-02 1997-07-02 In vivo zeroing of catheter pressure sensor
US887481 1997-07-02

Publications (3)

Publication Number Publication Date
EP0888744A2 true EP0888744A2 (de) 1999-01-07
EP0888744A3 EP0888744A3 (de) 1999-12-15
EP0888744B1 EP0888744B1 (de) 2002-10-02

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US (1) US6120457A (de)
EP (1) EP0888744B1 (de)
JP (1) JP4201884B2 (de)
DE (1) DE69808383T2 (de)

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DE69808383D1 (de) 2002-11-07
EP0888744B1 (de) 2002-10-02
JP4201884B2 (ja) 2008-12-24
DE69808383T2 (de) 2003-06-12
JPH11160180A (ja) 1999-06-18
EP0888744A3 (de) 1999-12-15
US6120457A (en) 2000-09-19

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